Evaluation of the Efficacy of Preoperative Ketamine Nebulization on Postoperative Sore Throat Due to Tracheal Intubation for Adult Patients Under General Anesthesia, A Prospective Randomized Controlled Study

Sore throat includes specific symptoms such as dysphagia, dysphonia, hoarseness, continuous throat pain, and pharyngeal dryness. Patients rated postoperative sore throat (POST) as the eighth most undesirable outcome in the postoperative period POST has a reported incidence of up to 62% following general anesthesia (GA). The incidence of POST is more common in GA with tracheal intubation than in GA with the supraglottic airway Ketamine is an N-methyl-D-aspartate (NMDA) receptor antagonist and has been used as a gargle for reducing the incidence and severity of POST due to its anti-nociceptive and anti-inflammatory effects

Study Overview

• Status: Not yet recruiting
• Conditions: Post Operative Sore Throat
• Intervention / Treatment: Drug: Ketamine; Other: saline nebulization

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Doaa A Abdellatif, resident; Phone Number: 01119950167; Email: doaaahmed@med.sohag.edu.eg
• Study Contact Backup: Name: fawzy A badawy, assistant professor; Phone Number: 01004862474

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

1. Age 16-60 years.
2. Of both sex.
3. American Society of Anesthesiologists Physical Status (ASA PS) I-II.
4. Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.

Description

Inclusion Criteria:

1. Age 16-60 years.
2. Of both sex.
3. American Society of Anesthesiologists Physical Status (ASA PS) I-II.
4. Undergoing general anesthesia with endotracheal intubation with surgery duration less than two hours.

Exclusion Criteria:

• a- History of chronic obstructive History of sore throat or upper respiratory tract infection.

  b- Intraoral and intrapharyngeal surgery. c- airway disease or Asthma. d- Mallampati grade more than II. e- Known allergic to study drug. f- More than one attempt is required for intubation. g- Hypertensive patients. h- Epileptic patients. i- cerebral palsy or any neurological disorders. j- Psychiatry patients. k- Cardiac patients. l- Perioperative use of anti-inflammatory drugs (Non-steroidal anti-inflammatory drug or steroids).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
(K) Ketamine group; 40 patients will receive ketamine 50mg (1.0 ml with 4.0 ml of the saline) nebulization	Drug: Ketamine; description
(S) Saline group; 40 patients will receive saline nebulization (5ml).	Other: saline nebulization; description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence and severity of POST	the study is to measure the incidence and severity of POST at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively. in adult patients undergoing surgery of a duration less than 2h.	at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.	evaluation of side effects including nausea, vomiting, cough, and dry mouth in both groups.	at immediate recovery (0 h), 2, 4, 6, 8, 12 and 24 h post-operatively.

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Cairns A, Battleday FM, Velikova G, Brunelli A, Bell H, Favo J, Patella M, Lindner O, Pompili C. General patient satisfaction after elective and acute thoracic surgery is associated with postoperative complications. J Thorac Dis. 2020 May;12(5):2088-2095. doi: 10.21037/jtd-19-3345b.
• Hailu S, Shiferaw A, Regasa T, Getahun YA, Mossie A, Besha A. Incidence of Postoperative Sore Throat and Associated Factors Among Pediatric Patients Undergoing Surgery Under General Anesthesia at Hawassa University Comprehensive Specialized Hospital, a Prospective Cohort Study. Int J Gen Med. 2023 Feb 18;16:589-598. doi: 10.2147/IJGM.S397519. eCollection 2023. Erratum In: Int J Gen Med. 2023 Apr 06;16:1237-1238.
• Thomas D, Bejoy R, Zabrin N, Beevi S. Preoperative ketamine nebulization attenuates the incidence and severity of postoperative sore throat: A randomized controlled clinical trial. Saudi J Anaesth. 2018 Jul-Sep;12(3):440-445. doi: 10.4103/sja.SJA_47_18.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: July 27, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 3, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Ketamine
• Other Study ID Numbers: soh-Med-23-07-20MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No